Monday, July 25, 2016

Commercialization of Molecular Diagnostics: NextGenDX Conference in DC, August 24-25

The multi-track Next Generation Diagnostics Conference is holdings its eighth annual event in Washington, August 23-26, 2016. The conference website is here.

Within the conference, I have the chance to chair a panel on PAMA. The panel includes Sylvia Trujillo of the AMA, Carol Blackford, Acting Director of the CMS Hospital and Ambulatory Policy Group, Brian Carey of Foley Hoag LLP and Rick Zimmerer, Life Sciences, KPMG.

I am planning to release, "An Innovator's Guide to PAMA" around the time of this panel.

This panel will kick off the conference track "Commercialization of Molecular Diagnostics," which runs August 24-25. The see this track's special webpage, here. Registration for the conference is open.

Details after the break.

The agenda for the Wednesday, August 25, PAMA panel is clipped below.

Other panels and speakers on Wednesday and Thursday will include: a keynote by Elizabeth Mansfield of the FDA, sessions on Value Capture for Advanced Diagnostics, sessions on the role of diagnostics, "From Volume to Value," how big should gene panels be, short courses on Wednesday evening with dinners, talks on "Surviving Payer Review," and how labs and LDTs are affected by payor and provider consolidation. Andrew Fish of AdvMedDX chairs a panel on what evidence is needed, with Liz Mansfield of FDA and speakers from Johns Hopkins and Geisinger. Several speakers, including Sean Tunis, will discuss where Liquid Biopsy is going, and the LBx panel will include Stephanie Schulman from the New York State labs program.

An overview of the Medicare Clinical Laboratory Fee Schedule provisions of the Preserving Access to Medicare Act of 2014 (PAMA) concerning coding, data collection and pricing, and coverage provisions. The foregoing will include highlights of coding issues raised by stakeholders, data collection challenges for clinical laboratories (particularly for physician office based laboratories), and possible coverage implications.

This session will discuss Medicare reform of the Clinical Laboratory Fee Schedule based on private payer prices. Topics will also include Medicare payment for advanced diagnostic laboratory tests, coding and pricing for new clinical diagnostic laboratory tests and more.

2:20 PAMA Reimbursement: Lessons from Pharma ASP Reporting

Rick Zimmerer, Partner, Life Sciences Advisory Services, KPMG LLP

PAMA’s price reporting and reimbursement system for laboratories was modeled on the ASP system that has applied to Medicare Part B drug reimbursement for over a decade. The laboratory industry has the opportunity to avoid mistakes and apply lessons learned from that program. This session will summarize key similarities and differences and explore key areas where lessons may be applicable.

An overview of the key provisions in the Medicare Clinical Diagnostic Laboratory Tests Payment System Rulemaking regarding coding, data collection and reporting, rate-setting and coverage for Advanced Diagnostic Laboratory Tests (ADLTs). In particular, the presentation will address time line for PAMA implementation, including payment for New ADLTs at Actual List Charge and annual data collection and reporting.

About the Author

Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.